Implantable mesh and method of use

ABSTRACT

A method of using an implantable mesh for repairing a tissue defect or reconstructing tissue, wherein the implantable mesh has a mesh body and at least two mesh extensions comprised of mesh extending therefrom, includes positioning the mesh body of the implantable mesh such that the mesh body extends across the tissue defect or tissue to be reconstructed and passing at least one mesh extension through tissue adjacent to the tissue defect or tissue to be reconstructed so as to anchor the implantable mesh to the tissue and resist high tension without dehiscing or migrating from the tissue defect or tissue to be reconstructed.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 15/508,545, filed on Mar. 3, 2017, which is a National Phase ofPCT/US2015/048557, filed on Sep. 4, 2015, which claims the benefit ofpriority of United States Provisional Patent Application Nos.62/045,718, filed Sep. 4, 2014; 62/091,798, filed Dec. 15, 2014; and62/105,927, filed Jan. 21, 2015, all of which are incorporated herein byreference in their entireties.

FIELD

The present disclosure relates to a device and method of use forreconstructing and/or repairing tissue, such as a hernia repair,intended to reduce the likelihood of tissue failure. More specifically,this disclosure relates to an implantable mesh, and a method ofimplantation therefor, that distributes tensile stress over a largerarea between the implantable mesh and the surrounding tissue and,thereby, provides increased durability and better surgical outcomes forpatients compared to currently-available devices and methods.

BACKGROUND

Mesh implants are used in many applications to repair or restructuretissue, such as, but not limited to, skin, fat, fascia, or muscle. Onecommon application for such mesh implants is in hernia repair, such asabdominal wall hernia repairs. A hernia is a protrusion of an organ ortissue through an opening or weakness in the walls that normally retainthe organ or tissue within a confined space. Most commonly, herniasoccur in the abdominal region; however, hernias may occur in manylocations throughout the body, including but not limited to the head,thorax/chest, pelvis, groin, axilla, and upper and lower extremities.Hernia is one of the most common surgical pathologies. Approximately 4million laparotomies are performed in the United States annually, and2%-30% of them result in incisional hernias. It is estimated thatapproximately 20 million inguinal hernia operations are performedglobally every year, and there are millions more incisional, ventral,and other types of hernias repaired. Traditionally, there are three mainapproaches to surgical hernia repairs: open, laparoscopic, and robotichernioplasty. In all three types of repairs, the repaired tissue isreinforced by applying a mesh implant, which may be comprised ofsynthetic or biologic materials.

Hernias have a tendency to reoccur, and recurrence rates in open surgeryhave been reported to range from 15-25%. Current recommendations forhernia repair include the use of mesh implants because patients whoundergo hernia repair without mesh experience a three-fold increase inrecurrence rates compared to patients who undergo hernia repair with amesh implant.

SUMMARY

This Summary is provided to introduce a selection of concepts that arefurther described below in the Detailed Description. This Summary is notintended to identify key or essential features of the claimed subjectmatter, nor is it intended to be used as an aid in limiting the scope ofthe claimed subject matter.

In one embodiment, an implantable mesh for use in reconstructing tissueincludes a mesh body having a surrounding edge and one or more meshextensions extending from the surrounding edge of the mesh body. Eachmesh extension has a first end and a second end. The first end isintegrated into or part of the mesh body, and a fixation device is atthe second end.

In another embodiment, an implantable mesh for use in reconstructingtissue includes a mesh body and one or more extensions extending fromthe mesh body. Each mesh extension has a first end and a second end,wherein the first end of the mesh extension is integrated into or partof the mesh body. Each mesh extension is configured to permit multipleanchor points with surrounding tissue upon implantation.

In another aspect, methods of using the claimed implantable mesh inreconstructing tissue or repairing a tissue defect includes positioningthe implantable mesh such that the mesh body extends across the tissuedefect or tissue to be reconstructed. The method further comprisesaffixing the implantable mesh to surrounding tissue by anchoring eachmesh extension to multiple anchor points in the surrounding tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is described with reference to the followingFigures. The same numbers are used throughout the Figures to referencelike features and like components.

FIG. 1A provides an exemplary embodiment of an implantable meshaccording to the present disclosure.

FIG. 1B provides another exemplary embodiment of an implantable meshaccording to the present disclosure.

FIG. 2 schematically depicts another exemplary embodiment of animplantable mesh according to the present disclosure.

FIG. 3 schematically depicts another exemplary embodiment of animplantable mesh according to the present disclosure.

FIG. 4 schematically depicts yet another exemplary embodiment of animplantable mesh according to the present disclosure.

FIGS. 5A and 5B schematically depict an embodiment of an implantablemesh implanted in a patient to repair an abdominal hernia.

FIGS. 6A-6D depict various embodiments of weave patterns for affixing animplantable mesh to surrounding tissue.

FIG. 7 is a flowchart depicting one embodiment of a method of using theimplantable mesh of the present disclosure in reconstructing orrepairing a tissue defect.

FIG. 8 is a graph depicting the load-bearing capabilities of theimplantable mesh of the present disclosure as compared to a prior artdevice and method.

DETAILED DESCRIPTION

In the present description, certain terms have been used for brevity,clarity and understanding. No unnecessary limitations are to be inferredtherefrom beyond the requirement of the prior art because such terms areused for descriptive purposes only and are intended to be broadlyconstrued.

FIG. 1A depicts one embodiment of an implantable mesh 1 having a meshbody 7 and multiple mesh extensions 3 extending from opposing sides ofthe mesh body 7. At the end of each mesh extension 3 is a fixationdevice 5, which in the depicted embodiment is a surgical needle. Eachmesh extension 3 has a first end 11 that is part of and extends from themesh body 7. Each mesh extension 3 also has a second end 12 thatattaches to the fixation device 5. Each mesh extension 3 has a length 14between the first end 11 and the second end 12 and a width 15.

The mesh body 7 has a surrounding edge 9 from which the mesh extensions3 extend. At least two mesh extensions 3 extend from the mesh body 7,and, in various embodiments, the implantable mesh 1 may have any numberof additional mesh extensions 3. In the embodiment of FIG. 1A, theimplantable mesh 1 has ten mesh extensions 3 arranged in opposing pairsextending oppositely from surrounding edges 9 of the mesh body 7. InFIG. 1A, the mesh extensions 3 extend from only two of the surroundingedges 9. The mesh extensions 3 may extend from more than two or even allof the surrounding edges 9. The mesh extensions 3 are separated byspacing 16 between each mesh extension 3. As depicted, the meshextensions 3 may be evenly spaced such that the spacing 16 between eachmesh extension 3 is equal. In other embodiments, the mesh extensions 3may be arranged with varied spacing 16 therebetween. For example,certain portions of the surrounding edge 9 may have more mesh extensions3 that are closer together than at other portions of the surroundingedge of the implantable mesh 1.

The mesh extensions 3 of the implantable mesh 1 have sufficient length14 to permit multiple anchor points with surrounding tissue uponimplantation. An anchor point is a position where the mesh extensionpasses through some portion of the surrounding tissue in order toprovide a force against migration or dehiscence. Multiple anchor pointsrefers to more than one anchor point. For example, each mesh extension 3may be passed through the surrounding tissue multiple times, such as byweaving or sewing the mesh extensions 3 into the tissue with thefixation device 5. Additionally, in some embodiments the distal end 12of the mesh extension 3 may be secured to bone. Thereby, the implantablemesh 1 of the present disclosure is configured such that, uponimplantation, it can withstand substantial forces, including tensilestress, without failure. This device and method of use is especiallyapplicable for providing a durable reconstruction or repair of a tissuedefect, such as a repair of an abdominal hernia or a breastreconstruction.

For example, in standard of care hernia/tissue repair with mesh, themesh is typically secured to tissue using fixation devices, such assutures or tacks. With increased intra-abdominal pressure, abdominalwall muscle contraction (e.g. the external oblique, internal oblique, ortransversalis muscles), or other externally or internally appliedforces, tensile stress is placed on the mesh, fixation device, andtissue at each point where the mesh is secured to the tissue. Whentensile stress exceeds tensile strength of any of the mesh, fixationdevice, or tissue, failure ensues and mesh migration or mesh dehiscenceoccurs. Tensile Stress (σ) refers to stress caused by an applied force(F) that acts to elongate a material along the axis of the appliedforce. Force is distributed over area (A) of material and the anchorpoints which affix the material to another material. This may berepresented by the equation: σ=F/A. Tensile strength refers to themaximum tensile stress that a material can withstand before yielding, ordeforming in shape, and then fracturing or separating in structure, ortearing away (migrating or dehiscing) from another material to which itis affixed at anchor points.

Mesh migration and dehiscence lead to hernia recurrence. Mesh migrationrefers to movement of a portion of mesh away from one or more anchorpoints. In one aspect, a portion of the mesh may remain at its originalanchor points while another portion of the mesh moves away from one ormore anchor points. Dehiscence refers to movement of the entire meshaway from the original anchor points; i.e., none of the mesh remains atits original anchor points. In hernia repair, both mesh migration anddehiscence are frequently caused by tissue failure at the anchor points,and less frequently caused by fixation device failure or mesh failure.Tissue failure is the most common reason for mesh migration or meshdehiscence because the tensile strength of tissue is significantly lessthan the tensile strength of the mesh or the fixation device used toattach the mesh to the tissue at anchor points. Tissue failure occurs atanchor points because tensile stress is distributed over a narrow areaof tissue and the tensile stress exceeds the tensile strength of thetissue.

Through experience and research in the relevant field, the presentinventor has recognized these problems related to mesh migration ordehiscence and the need for a device and method to avoid tissue failureat anchor points by increasing the area over which tensile stress isdistributed to the surrounding tissue. In effect, the mesh implant 1 andassociated method of implantation reduces the tensile stresses appliedto the anchor points to amounts that are less than the tensile strengthof the tissue at the anchor points. Specifically, the inventor hasdeveloped the presently disclosed implantable mesh 1 to avoid failure atthe mesh-tissue interface, enabling the mesh to remain anchored into thetissue and withstand forces which would cause prior art mesh devices tomove or be pulled from the surrounding tissue, such as the abdominalwall, due to intra-abdominal pressure, muscular pull or other suchexternal or internally applied forces. For example, the present inventorhas recognized that anchor points of an implantable mesh should be ableto withstand a tensile stress of at least 16 newtons (N)/centimeter(cm), or greater, because 16N/cm is approximately the maximumphysiologic abdominal stress a human can generate. In other embodiments,the presently disclosed implantable mesh 1 implanted in a patient isable to withstand a range of forces of at least 16 N/cm, at least 24N/cm, at least 28 N/cm, at least 30 N/com, at least 40 N/cm, or at least48 N/cm without migrating or dehiscing. In another embodiment, theimplantable mesh 1 implanted in a patient is able to withstand a rangeof forces equal to or greater than 100 N/cm without migrating ordehiscing. In one aspect, the invention achieves this goal by elongatingthe area of anchor points and by having multiple anchor points ofcontact between the mesh extensions and surrounding tissue.

The presently disclosed implantable mesh 1 implanted in a patient isable to withstand the range of forces described above within a shorttime after implantation of the implantable mesh. For example, theimplantable mesh 1 can withstand such forces immediately afterimplantation, within one week, two weeks, three weeks, four weeks, sixweeks, two months, three months, four months, or five months afterimplantation. Some mesh implants are dependent upon tissue ingrowth intothe mesh or the anchor points to allow for greater tensile strength andto avoid migration or dehiscence of the implant. These mesh implants areprone to acute failure. The implantable mesh provided herein isimmediately woven into the tissue and the fixation strength immediatelyexceeds the threshold of 16N/cm as shown in the Examples.

By providing multiple anchor points over an elongated area, tensilestress on the tissue and the implant 1 is distributed over a largerarea, rather than concentrated at single points of fixation between themesh and the surrounding tissue, such occurs with suture fixation.Thereby, an implantable mesh 1 implanted according to methods describedherein is able to withstand increased tensile stress compared to priorart devices that are sutured to surrounding tissue by conventionalanchoring methods. One force distribution mechanism at play isfrictional resistance, which is distributed across numerous points ofcontact between the implantable mesh 1 and the surrounding tissue. Theamount of frictional resistance between the implantable mesh 1 and thetissue may depend on numerous factors, including, but not limited to,the area over which the tensile stress is distributed, forces that pressthe mesh into the tissue, the relative roughness of the mesh and thetissue, the method of fixation, and the extent of bioincorporation ofthe mesh into the tissue. As long as frictional resistance exceedstensile stress at each of the anchor points, or points of contact, themesh will not migrate or dehisce.

In an exemplary embodiment, the length 14 of the mesh extensions 3 is atleast 10 cm. In another embodiment, the length 14 of the mesh extensions3 is at least 16, 18 or 20 cm long and may be up to 25, 30, 35 or 40 cmlong; and in still other embodiments the mesh extensions 3 may be evenlonger than 40 cm to allow for fixation to certain tissues or for thedistal end 12 of the mesh extension 3 to be fixed to bone. However, incertain applications, the mesh extensions may be less than 10 cm, suchas where the implantable mesh 1 is small and/or intended for repair orreconstruction of tissue that does not withstand significant forces. Themesh extensions 3 of the implantable mesh do not need to all be the samelength. In one embodiment, at least one mesh extension is at least 18,20 or 22 cm long, but the implantable mesh may include additional meshextensions that are less than 18 cm long or longer than 22 cm long.

The mesh extensions 3 may have any of various widths. In the embodimentof FIG. 1A, the width 15 of each mesh extension is the same, and thespacing 16 between each mesh extension 3 is wider than the width 15 ofeach mesh extension. For the embodiment of FIG. 1A, the width 15 of eachmesh extension 3 may be between 0.2 cm and 3 cm, or more. For example,experimentation and research by the inventor relating to abdominalhernia repairs has revealed that mesh extensions 3 having a width 15around 1 cm provide desirable durability results. In the embodiment ofFIG. 1A, where the width 15 of each mesh extension 3 is 1 cm, thespacing 16 may be 2 cm or 3 cm, or more. Likewise, in an embodimentwhere the width 15 of each mesh extension 3 is 3 cm, the spacing 16 maybe somewhere between 6 cm and 9 cm, or more. By contrast, the embodimentof FIG. 1B is configured such that the width 15 of each mesh extension 3is approximately the same as the spacing 16 between each mesh extension3. In an exemplary embodiment, the width 15 of each mesh extension 3 isbetween 0.2 cm and 3 cm, and the spacing 16 is the same. For example, inone preferred embodiment, the width 15 of each mesh extension 3 is 1cm-2 cm, and the spacing 16 between each mesh extension 3 is also 1 cm-2cm. However, other widths 15 and spacings 16 are contemplated as withinthe scope of disclosure, and one of skill in the art will appreciatethat various dimensions and configurations may be appropriate dependingon the tissue defect or reconstruction and surgical approach by whichthe implantable mesh 1 will be applied. Further, it will be understoodby one of skill in the art that any two values listed herein may becombined to provide value ranges for lengths or widths of portions ofthe implantable mesh, including the mesh extensions 3.

The length 14 of the mesh extensions 3 may also be related to the width15 of the mesh extensions 3 and the tissue in which the implantable meshis to be inserted. It is expected that mesh extensions having narrowwidths may be capable of being passed through the surrounding tissue atleast two times using a shorter length mesh extension. For example, ifthe mesh extension is 0.5 cm wide, the mesh extension may only need tobe 10 cm long to allow at least two passes through the surroundingtissue or to provide two anchor points per mesh extension. In anotherembodiment, the mesh extensions 3 may be 2 cm wide and 30 cm long toallow adequate anchor points after implantation.

In FIGS. 1A and 1B, the implantable mesh 1 is depicted as including tenmesh extensions 3 with five mesh extensions extending from thesurrounding edge 9 on opposite sides of the mesh body 7. As noted above,the mesh extensions 3 may extend from one or more of the surroundingedges 9 of the mesh body 7. In addition, various embodiments may includevarious numbers of mesh extensions 3. For example, the implantable meshmay include two, three, four, five, six, seven, ten, twelve, fourteen oreven more mesh extensions. The number of mesh extensions required maydepend on characteristics known to those skilled in the art such as thesize and placement of the tissue defect or reconstruction site and theavailability or proximity of the surrounding tissue to the tissue defector site of reconstruction. Having fewer mesh extensions whilemaintaining or reducing the risk of mesh migration or dehiscence ascompared to the standard of care may be advantageous for variousreasons. For example, fewer mesh extensions may decrease manufacturingand packaging costs. In addition, as noted in the Examples the amount oftime required for implantation is related to the number of meshextensions and the number of times the mesh extension is passed throughthe tissue. Reducing the number of mesh extensions may decrease thelength or complexity of the surgery or result in decreased damage andconcomitant pain for the patient recipient of the implantable mesh.

As depicted in FIGS. 1A and 1B, the mesh extensions 3 may be of uniformmesh construction with the mesh body 7. In such an embodiment, the meshextensions 3 and the mesh body 7 may be comprised of the same set ofmesh threads 8 woven or knitted together to form a continuous meshpattern. In general, the mesh is an arrangement of biocompatible threadsthat form a flexible material, for example a knitted material, wovenmaterial, a non-woven material, or a braided material. For example, themesh may be of an openwork structure or pattern, i.e. having pores toencourage tissue in-growth. Such a mesh may be bioabsorbable, partlybioabsorbable or permanent. The organization of the mesh fibers 8 (inknitted material, woven material, braided material, etc.) or surfacestructure (e.g., in non-woven material) in the mesh extensions 3 may becontrolled by methods known in the art to optimize the biomechanicalproperties, such as tensile strength, as well as for porosity,morphology, and geometry as they relate to tensile strength andbioincorporation, which also influences tensile strength and frictionalresistance. Various knitting techniques known in the art may be used tocreate the mesh of the implantable mesh 1. These include, but are notlimited to, warp knitting, weft knitting, and circular knitting.Alternatively or additionally, various weaving techniques known in theart may be used to create the mesh of the implantable mesh 1. Theseinclude, but are not limited to, hexagonal open stitching (e.g.,PARIETINE® mesh), interlocking fiber junctions (e.g., PROLENE® mesh,SURGIPRO Pro® mesh), diamond shape open stitching (e.g., ULTRAPRO®mesh), 2-dimensional weaves, and 3-dimensional weaves.

The mesh threads 8 may be, for example, monofilaments, braided, or acombination of monofilament and braided. Further, the mesh threads 8 maybe coated to enhance tensile strength, frictional resistance, andbioincorporation. The mesh may be comprised of any biocompatiblematerial that has the properties (e.g. tensile strength, durability,etc.) to withstand the forces described herein when implanted in tissue.In some embodiments the mesh comprises a synthetic mesh, which is a meshmade from biocompatible and synthetic materials, including, but notlimited to, polypropylene, polyethylene terephthalate polyester,expanded polytetrafluroethylene (ePTFE), polyglactin, polyglycolic acid,trimethylene carbonate, poly-4-hydroxybutyrate (P4HB), polyglycolide,polyactide, and trimethylene carbonate (TMC). In other embodiments, themesh comprises a biological mesh, which is a mesh made frombiocompatible and biological materials, including, but not limited to,human dermis, porcine dermis, porcine intestine, bovine dermis, andbovine pericardium. The mesh may also be a comprised of a combination ofsynthetic and biologic materials.

In another embodiment, the mesh extensions 3 are formed of a differentconstruction. In the embodiment of FIG. 2, the mesh extensions 3 areformed by ends 8 a of the mesh threads 8. For example, one or both endsof the threads 8 woven or knitted together to form the mesh body 7 mayextend outward from the mesh body 7 to form the mesh extensions 3. FIGS.3 and 4 depict another embodiment where the mesh extensions 3 arecomprised of mesh threads 8 c woven or knitted together separately fromthe mesh threads 8 b of the mesh body 7. The mesh threads 8 c at thefirst end 11 of the mesh extensions 3 are then integrated into the meshbody 7, such as woven into the mesh body 7.

Like the mesh threads 8 b of the mesh body 7, the mesh threads 8 c ofthe mesh extensions 3 may be woven together in any pattern, includingany of those referenced hereinabove. In the example depicted in FIG. 3,the mesh extensions are comprised of mesh threads 8 c twisted intohelixes. The number of mesh threads 8 c forming the helix for eachexemplary mesh extension 3 may vary to allow for different thicknesses.Depending on the tissue to which the device will be fixed, the thicknessand length of each of the helical mesh extensions 3 may be different.

The threads 8 c of at the first end of each mesh extension 3 may beintegrated into the mesh body in various ways. For example, as depictedin FIG. 3, the mesh threads 8 c of the mesh extensions are woven intothe mesh of the mesh body 7 and extend part way across the mesh body 7.In other embodiments, the mesh threads 8 c of the mesh extensions 3 maybe woven all the way across the mesh body 7. In still other embodiments,such as that depicted in FIG. 4, the mesh extensions 3 are comprised ofmesh threads 8 c woven all the way across the device, such that opposingmesh extensions 3 are formed of the same mesh threads 8 c. In such anembodiment, the woven mesh threads 8 c of the mesh extension 3 arepassed through the mesh body 7. The embodiments of FIGS. 3 and 4 may beespecially useful where the mesh body 7 and the mesh extensions 3 arenot comprised of the same material. For example, in the embodiment ofFIG. 4, the mesh body 7 may be comprised of biologic material, and themesh extensions 3 may be comprised of synthetic material, or vice versa.Exemplarily, the mesh threads 8 c of the mesh extensions 3 may be, forexample, polypropylene threads woven together in a helical pattern. Thehelical woven mesh extensions 3 may then be woven through a mesh body 7,which may be comprised of a biological material described and listedabove.

The implantable mesh 1 may be produced from one layer of mesh material,or from a plurality of layers of mesh materials, which may be the sameor different materials arranged in the same or different construction.Additionally, the implantable mesh 1 may be any shape or configurationthat provides a mesh body and at least two mesh extensions extendingtherefrom. In some embodiments, the mesh body 7 may be circular, oval,rectangular, square, triangular, or any other multi-sided shape.Additionally, the mesh extensions 3 may vary in shape and dimension.

Various fixation devices 5 may be at the second end 12 of each meshextension 3. The fixation devices 5 may be any element or series ofelements that enable fixation of the mesh extension to the tissue.Exemplary fixation devices include, but are not limited to, surgicalneedles, staples, tacks, screws, laser-assisted tissue welding, fibrinsealant, glue, salute “Q” ring, Mitek anchors, and/or sutures. Eachfixation device 5 may be permanently or removably attached to the secondend 12 of each mesh extension 3. Alternatively or additionally, thefixation device 5 may be permanently or removably attached to some otherportion of each mesh extension 3. Moreover, the fixation device 5 may bean element that is permanently implanted in the patient, or is removedfrom the implantable mesh 1 once it is implanted in the patient.

In the examples of Figures of 1A, 1B, 2, and 4, the fixation devices 5are surgical needles. In those embodiments, the surgical needles arethere to assist in affixing the mesh extensions 3 into the surroundingtissue—i.e. to allow the surgeon to pass the mesh extensions 3 throughthe surrounding tissue. In such embodiments, once the mesh extensions 3have been passed through the surrounding tissue a sufficient number oftimes, which may be the number of times that the length 14 of the meshextension 3 will allow in a particular application, the mesh extension 3may be cut at the second end 12 to remove the surgical needle fixationdevice 5. FIG. 3 depicts another embodiment where the fixation device 5is a tack. In one embodiment, the tacks 5 may be attached at the secondend 12 of each mesh extension 3 once the mesh extension 3 has been woveninto or affixed to the surrounding tissue. In such an embodiment, thetacks 5 may operate to anchor the mesh extensions to the tissue or tosurrounding bone. In similar embodiments, multiple tacks may be used atvarious locations along the mesh extensions 3 to provide multipleadditional anchor points. Such an embodiment utilizing tacks may beappropriate, for example, in laparoscopic surgeries and/or in robotichernia prostheses.

When implanted, the implantable mesh 1 is affixed to the tissue defector the tissue to be reconstructed and/or the surrounding tissue atmultiple anchor points. This may be executed by passing each meshextension through the surrounding tissue, such as by weaving or knitting(i.e., no sutures) the mesh, mesh extension, fixation device and/orextension means into the tissue (e.g., abdominal fascia). In oneembodiment, the implantable mesh 1 is implanted into a patient forreconstructing or repairing a tissue defect, such as a hernia, or abreast reconstruction. The tissue is penetrated at an entry point, suchas at the location of a hernia, or at an incision or a surgicalseparation of tissue. The implantable mesh 1 is then positioned so as toenable reconstruction or repair of the tissue defect. For example, theimplantable mesh 1 may be positioned such that the mesh body 7 extendsacross the tissue defect. The mesh extensions are then anchored to thesurrounding tissue at multiple anchor points, such as by weaving orpassing the mesh extension 3 into or through the surrounding tissue 30using one or more of the patterns exemplified in FIGS. 6A-6D, discussedhereinbelow.

FIGS. 5A and 5B demonstrate an exemplary use of the implantable mesh 1to repair an abdominal hernia, where each figure depicts the implantablemesh 1 at a possible location for repairing a hernia. However, in otherembodiments and situations, the implantable mesh 1 may be placed in anyone or more of several different anatomic planes, depending on thehernia, the patient's anatomy, the fixation method, surgeon's judgment,etc. In the example of FIGS. 5A and 5B, the implantable mesh 1 islocated on the posterior abdominal fascia 22. In other embodiments andimplantation methods, the implantable mesh 1 may be located at anynumber of other locations along the abdominal wall, such as on anteriorabdominal wall as an onlay, within the muscle of the abdominal wall asan inlay, below the muscle of the abdominal wall as a sublay, or as anunderlay. The mesh may be placed extraperitoneal or intraperitoneal, orin any number of other locations for abdominal hernia repair.

In the examples of FIGS. 5A and 5B, the hernia has occurred between therectus abdominis muscles 28. In such an embodiment, an incision may bemade in the skin 24 so that the herniated area may be accessed. Theherniated area between the rectus abdominis muscles 28 may bepenetrated, and any tear or separation of the posterior abdominal fasciamay be repaired with sutures 26. The implantable mesh 1 is then placedsuch that the mesh body 7 extends across the herniated area. The meshextensions 3 are then passed through tissue surrounding the hernia, suchas by weaving the mesh extensions 3 into the surrounding tissue. In theexample of FIG. 5A, the implantable mesh 1 overlays the posteriorabdominal fascia and below the rectus muscles. The mesh extensions 3 arewoven into the posterior abdominal fascia 22 to form multiple anchorpoints 20 with the surrounding tissue in order to provide a forceagainst mesh migration or dehiscence and to protect the primary repairof the midline fascia. In the embodiment of FIG. 5B, the mesh extensions3 are affixed more laterally than in FIG. 5A and include passes throughthe oblique muscles 29 and their fascia.

Once the implantable mesh 1 is affixed to the surrounding tissue, thetissue above the implantable mesh 1 may be closed with sutures 26. Inthe exemplary situation depicted in FIGS. 5A and 5B, sutures 26 areplaced to close the anterior fascia 23 of the rectus abdominis muscle28, and then also to close the skin 24. Implanted in this exemplaryfashion, the implantable mesh 1 will remain in place and not migrate ordehisce because the mesh extensions 3 are arranged to have multipleanchor points 20 throughout the surrounding tissue 30 so as todistribute forces over a large area of tissue and prevent tissuefailure.

In another embodiment of a method of use, the implantable mesh 1 isutilized to reconstruct breast tissue by anchoring the device to thebreast tissue, chest wall, or rib bone. Currently, synthetic andbiologic meshes are used in breast reconstruction surgery in an attemptto solve the problem of implant malposition or of the implant pushingagainst the skin envelope and causing the wound to open, the breast todeform, or the skin to become thinned-out. However, due to tissuefailure, standard mesh fixation methods are often ineffective in holdingthe mesh to the pectoral muscle and/or the ribs. The presently disclosedimplantable mesh 1 and corresponding method of implantation provides aneffective solution to these problems presented in reconstructing breastsbecause, as described thoroughly above, they allow multiple fixationpoints and provide greater tissue fixation compared to sutures. Also,the mesh may function as a scaffold helping native tissue in-growth.Moreover, in certain embodiments and implantation methods, the meshextensions 3 may be of sufficient length that they may be fixed orconnected to the ribs, such as by stapling, tacking, or tying the meshextensions 3 to the ribs.

The patterns for affixing the device to the surrounding tissue may varywidely, including, but not limited to, a locking x-weave pattern, anx-weave pattern, or a plus weave pattern, as per the surgeon'sexpertise. FIGS. 6A-6D exemplify various weave patterns that may be usedto affix the implantable mesh 1 to tissue 30. FIG. 6A exemplifies anembodiment with the mesh extensions 3 woven into surrounding tissue 30in an x-weave pattern. FIG. 6B exemplifies an embodiment with the meshextensions 3 woven into surrounding tissue 30 in a locking x-weavepattern. FIG. 6C exemplifies an embodiment with the mesh extensions 3woven into surrounding tissue 30 in a plus weave pattern. FIG. 6Dexemplifies an embodiment with the mesh extensions 3 woven intosurrounding tissue 30 in a longitudinal weave pattern. FIG. 6D alsodemonstrates a varied longitudinal weave pattern, where the length ofthe weave stitches and the anchor point locations are varied betweenadjacent mesh extensions 3 so as to avoid concentrating forces, such astensile stress, on certain areas of tissue 30. The extensions may alsobe woven into tissue at a point remote from the primary hernia repair,where tissue integrity is superior. For example, select patients willoften have compromised fascia from circumstances such as but not limitedto previous surgeries or from their body habitus (e.g., morbid obesity)or from their disease states or from medicants like steroids.

Thereby, the forces may be dispersed and evenly distributed across alarger area of tissue 30. As the extensions are secured to thesurrounding tissue, one or more knots of the mesh extensions 3 to thesurrounding tissue 30 may also be formed, which may vary in theirconfiguration to enhance fixation to the tissue 30. In some embodimentsof implantation methods, one or more sutures may also be used to furthersecure the mesh extensions 3 to the surrounding tissue 30. For example,sutures may be used to tie a knot around the extension, similar to howPulver-Taft weaves are secured in tendon repair.

FIG. 7 presents a flow chart exemplifying one method 50 of using theimplantable mesh 1 in reconstructing or repairing a tissue defect.First, the tissue is penetrated at an entry point at step 51. Theimplantable mesh 1 is then inserted through the entry point at step 52,and the mesh body 7 is positioned across the tissue defect at step 53.The mesh extensions 3 are then woven into the surrounding tissue, suchas by using a surgical needle fixation device 5 attached to distal endof each mesh extension 3. At step 55, the surgical needle fixationdevice 5 may then be removed from each mesh extension 3, for example bycutting the end 12 of each mesh extension 3.

FIG. 8 provides a graph comparing the load-bearing capabilities of theimplantable mesh 1 and the current standard of care mesh fixation methodusing sutures. Line 41 of the graph demonstrates the load versusdisplacement of the implantable mesh 1 when affixed to the abdominalfascia according to some embodiments of the present disclosure. Line 43of the graph demonstrates the load versus displacement of a standardhernia mesh affixed to the abdominal fascia using current standard ofcare suturing techniques. The graph demonstrates that the implantablemesh device 1, implanted using the methods disclosed herein, providesfar superior stress shielding of the tissue (i.e., lowering the tensilestress on the tissue at anchor points below the tensile strength of thetissue). As described above, the present inventor has recognized that aimplantable mesh 1 should be able to withstand a tensile stress of atleast 16 N/cm without migrating or dehiscing. Line 45 marks this minimumload requirement. As the graph demonstrates, the current standard ofcare mesh fixation provides a maximum load-bearing strength of just over5 N/cm, which is significantly less than this minimum requirement of 16N/cm. The embodiment of the implantable mesh 1, on the other hand,provides load-bearing strength that well-exceeds the exemplary minimumrequirement of 16 N/cm.

The use herein of the terms “including,” “comprising,” or “having,” andvariations thereof, is meant to encompass the elements listed thereafterand equivalents thereof, as well as additional elements. Embodimentsrecited as “including,” “comprising,” or “having” certain elements arealso contemplated as “consisting essentially of” and “consisting of”those certain elements.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. For example, if a concentration range isstated as 1% to 50%, it is intended that values such as 2% to 40%, 10%to 30%, or 1% to 3%, etc., are expressly enumerated in thisspecification. These are only examples of what is specifically intended,and all possible combinations of numerical values between and includingthe lowest value and the highest value enumerated are to be consideredto be expressly stated in this disclosure.

The following examples are meant only to be illustrative and are notmeant as limitations on the scope of the invention or of the appendedclaims.

EXAMPLES

Bench top studies were conducted comparing the standard of care meshimplant and fixation method to the implantable mesh 1 and implantationmethod disclosed and described herein. Human abdominal tissue 30 wasmodeled in hemi-dumbbell shaped porcine abdominal wall segments sized at12 cm×10 cm×0.5 cm. For the standard of care device and fixation method,Ethicon Ultrapro Monocryl Prolene Composite mesh was anchored to thehemi-dumbbell swine specimen with four discrete 0 polypropylene suturesat 1 cm intervals. The sutures were fixed at the third pore from theedge of the mesh. To model the implantable mesh 1, an Ethicon UltraproMonocryl Prolene Composite mesh was cut with a scissor to model a meshbody 7 with mesh extensions 3 measuring 1 cm in width and 30 cm inlength. The mesh extensions 3 were woven into the hemi-dumbbell swinespecimen using four running locking stitch patterns, and no sutures orknots were used. The opposing edge of the mesh on both samples wasgripped with an instron. The two sides were then distracted at 100 mmper minute until the mesh completely dehisced from the tissue and/ortotal tissue failure was achieved. Load and displacement data wereacquired at a sample rate of 100 hz. Force displacement was obtained andconverted to stress displacement to interpret UTS. The UTS was recordedas N/cm, where N was the force applied until failure and cm was theoutermost distance between the furthest apart mesh extensions.

The standard of care fixation method and device, using the four discrete0 Surgipro polypropylene sutures, dehisced from the tissue 30 at about30N total force as the sutures pulled out of the tissue and remainedattached to the mesh. The tissue generally failed at or near the fouranchor points created by the four discrete 0 Surgipro polypropylenesutures. This is significantly less than the force tolerated by thesample using the mesh implant 1 affixed according to the methodsdisclosed herein. The implantable mesh 1 with the mesh extensions 3woven into the tissue 30 using four running locking stitch patterns didnot dehisce from the tissue until about 121N total force. The meshextensions dehisced by gradually slipping out of the tissue 30, ratherthan by the tissue failing.

Further tests were conducted under similar conditions modifying othervariables, including weave pattern, mesh throw count, and interspacedistance between each mesh extension. To test which weave patternprovided the most strength, three mesh extensions were woven into onehemi-dumbbell shaped fascia-muscle slab of porcine abdominal wall inpre-determined weave patterns, including a running x weave pattern,locking x weave pattern, a continuous locking pattern and a linearparallel pattern. The standard of care mesh fixation using sutures asdescribe above was also included. The number of throws was held constantat 4 throws. Following the four throws, the mesh ribbon was anchored tothe tissue with a surgeon's knot. Time taken to weave each elongationarm was recorded and averaged for each group. The samples were exposedto increasing tensile stress as described above.

Mode of failure for the standard of care mesh was by anchor pointfailure. Mode of failure for all woven meshes was remote tissue failure,or failures distal to weave anchor points. The following table providesthe data:

UTS Time to suture (N/cm) mesh extension (s) Standard of Care 12.8 18X-Weave 33.7 63 X-Locking 29.4 71 Continuous 39.2 54 Locking LinearParallel 24.8 37

To test which number of throws provided the most strength, the followingtest was performed. Three mesh ribbons were woven into one dumbbellshaped fascia-muscle slab of porcine abdominal wall, according to theabove-description, using an x-locking weave pattern with each of 2, 3,and 4 throws. The standard of care mesh fixation using sutures asdescribe above was also included. Each fixation method was tested intriplicate. Interspace distance was held constant at 1 cm. Time taken toweave each ribbon was recorded and averaged for each group. The sampleswere exposed to increasing tensile stress as described above. Forcedisplacement was obtained and then converted to stress-displacement tointerpret ultimate tensile strength (UTS). Mode of failure for thestandard of care mesh was by anchor point failure. Mode of failure forall woven meshes was remote tissue failure, or failures distal to weaveanchor points. The following table provides the data:

UTS (N/cm) Time to suture mesh extension (s) Standard of Care 11.2 19 4throws 41.8 65 3 throws 71.4 47 2 throws 45.0 33

To test which interspace distance between the mesh extensions providedthe most strength, the following test was performed. Two mesh ribbonswere woven into one dumbbell shaped fascia-muscle slab of porcineabdominal wall using an x-locking weave pattern. The interspace distancewas modified for each sample, including at 1 cm, 2 cm, and 3 cm, andeach was tested in triplicate. The number of throws was held constant atthree throws. Time taken to weave each ribbon was recorded and averagedfor each group. The samples were exposed to increasing tensile stress asdescribed above. Force displacement was obtained and then converted tostress-displacement to interpret UTS. Mode of failure for the standardof care mesh was by anchor point failure. Mode of failure for all wovenmeshes was remote tissue failure, or failures distal to weave anchorpoints. The following table provides the data:

UTS Time to suture mesh extension (N/cm) (s) Standard of 13.6 18 Care3.0 cm 24.7 61 Interspace 2.0 cm 36.1 61 Interspace 1.0 cm 31.8 61Interspace

To test which width of mesh extension provided the most strength, thefollowing test was performed. Two mesh ribbons were woven into onedumbbell shaped fascia-muscle slab of porcine abdominal wall using anx-locking weave pattern. The mesh arm width was modified for eachsample, including 1 cm, 1.5 cm, and 2 cm, and each was tested intriplicate. The number of throws was held constant at three throws andinterspace distance held constant at 1 cm. Time taken to weave eachribbon was recorded and averaged for each group. The samples wereexposed to increasing tensile stress as described above. Forcedisplacement was obtained and then converted to stress-displacement tointerpret UTS. Mode of failure for the standard of care mesh was byanchor point failure. Mode of failure for all woven meshes was remotetissue failure, or failures distal to weave anchor points. The followingtable provides the data:

UTS Time to suture mesh extension (N/cm) (s) Standard of 13.6 18 Care1.0 CM Width 39.7 54 1.5 CM Width 44.1 54 2.0 CM Width 33.5 59

To test whether a single pass through the surrounding tissue would offersufficient tensile strength, the following test was performed. AnEthicon Ultrapro Monocryl Prolene Composite mesh was cut with a scissorto create mesh extensions measuring 2.0 cm in width and 15.0 cm inlength. Two mesh extensions were placed per specimen at 2 cm intervals.As above, hemi-dumbbell shaped porcine abdominal wall segments(14-cm×19-cm×0.5-cm) cut for optimal tensile strength testing capabilitywere used as the specimen. Two small bilateral 2 mm holes were made ineach tissue specimen. A mesh extension was pulled through each hole. Allvariables were compared to Ethicon Ultrapro Monocryl Prolene Compositemesh anchored using simple interrupted 0 polypropylene sutures placed at1-cm intervals (standard of care). The sutures were passed through thethird pore from the edge of the mesh. Tensile strength testing wascarried out on an Instron according to ASTM specification D5034. Thegauge length (length of material between grips) was 200 mm composing 120mm of tissue and 80 mm of mesh. The displacement rate was 100 mm/minute.Load and displacement was recorded at a sampling rate of 100 Hz. Forcedisplacement was obtained and converted to stress displacement tointerpret UTS. The UTS was recorded as N/cm, where N was the forceapplied until failure and cm was the outermost distance between thefurthest apart mesh extensions.

UTS (N/cm) Time to suture mesh extension (s) Standard of Care 13.6 18Single Pass 2 cm 0.60 20 Mesh Extensions

No admission is made that any reference, including any non-patent orpatent document cited in this specification, constitutes prior art. Inparticular, it will be understood that, unless otherwise stated,reference to any document herein does not constitute an admission thatany of these documents forms part of the common general knowledge in theart in the United States or in any other country. Any discussion of thereferences states what their authors assert, and the applicant reservesthe right to challenge the accuracy and pertinence of any of thedocuments cited herein. All references cited herein are fullyincorporated by reference, unless explicitly indicated otherwise. Thepresent disclosure shall control in the event there are any disparitiesbetween any definitions and/or description found in the citedreferences.

We claim:
 1. A method of using an implantable mesh for repairing atissue defect or reconstructing tissue, wherein the implantable mesh hasa mesh body and at least two mesh extensions comprised of mesh extendingtherefrom, the method comprising: positioning the mesh body of theimplantable mesh such that the mesh body extends across the tissuedefect or tissue to be reconstructed; and passing at least one meshextension through tissue adjacent to the tissue defect or tissue to bereconstructed so as to anchor the implantable mesh to the tissue andresist high tension without dehiscing or migrating from the tissuedefect or tissue to be reconstructed.
 2. The method of claim 1, whereinthe step of passing the at least one mesh extension through the adjacenttissue includes passing the mesh extension through at least a portion ofthe adjacent tissue at least two times to create at least one anchorpoint.
 3. The method of claim 1, wherein the step of passing the atleast one mesh extension through adjacent tissue includes passing eachof the mesh extensions through at least a portion of the adjacent tissuemultiple times to create multiple anchor points.
 4. The method of claim1, wherein the step of passing at least one mesh extension throughadjacent tissue includes, with the mesh extension, performing at leastone throw of a stitch pattern through the adjacent tissue.
 5. The methodof claim 4, further comprising using a fixation device to pass the atleast one mesh extension through the adjacent tissue.
 6. The method ofclaim 5, wherein the fixation device is a surgical needle permanentlyconnected to an end of each mesh extension.
 7. The method of claim 1,wherein the tissue defect or tissue to be reconstructed is one ofabdominal tissue, breast tissue, or tendon.
 8. The method of claim 1,wherein the tissue defect or the tissue to be reconstructed is abdominaltissue, and wherein each mesh extension is passed through adjacentabdominal tissue.
 9. The method of claim 8, wherein the at least twomesh extensions extend oppositely from the mesh body to form at leastone opposing pair, and further comprising passing each of the meshextensions of the opposing pair through tissue on opposite sides of thetissue defect or tissue to be reconstructed so as to resist high tensionacross the abdominal tissue defect or abdominal tissue to bereconstructed.
 10. The method of claim 9, wherein the implantable meshhas at least four mesh extensions comprised of mesh and arranged in atleast two opposing pairs, and further comprising passing each of themesh extensions of each opposing pair through tissue on opposite sidesof the tissue defect or tissue to be reconstructed such that eachopposing pair resists high tension across the abdominal tissue defect orabdominal tissue to be reconstructed.
 11. The method of claim 1, whereinthe tissue to be reconstructed is an abdominal incision and wherein theimplantable mesh is positioned to prevent hernia formation at theabdominal incision.
 12. The method of claim 1, wherein the implantablemesh is anchored to the adjacent tissue so as to withstand a tensilestress of least 16 newtons per centimeter (N/cm) without migrating ordehiscing.
 13. A method of using an implantable mesh for repairing atissue defect or reconstructing tissue, wherein the implantable mesh hasa mesh body and at least two mesh extensions comprised of mesh extendingin opposite directions from the mesh body, the method comprising:positioning the mesh body of the implantable mesh such that the meshbody extends across the tissue defect or tissue to be reconstructed; andpassing each mesh extension through tissue on opposite sides of thetissue defect or tissue to be reconstructed to anchor the implantablemesh to surrounding tissue so as to resist high tension across thetissue defect or tissue to be reconstructed.
 14. The method of claim 13,further comprising passing each of the mesh extensions through at leasta portion of the surrounding tissue multiple times to create multipleanchor points.
 15. The method of claim 13, wherein the step of passingeach mesh extension through the adjacent tissue includes, with the meshextension, performing at least one throw of a stitch pattern through theadjacent tissue.
 16. The method of claim 15, further comprising passingthe mesh extension through itself to create a self-locking stitch. 17.The method of claim 15, further comprising using a fixation device topass through the adjacent tissue, wherein the fixation device is asurgical needle permanently connected to an end of each mesh extension.18. The method of claim 14, wherein the at least two mesh extensionsform at least one opposing pair, and further comprising passing each ofthe mesh extensions in the opposing pair through tissue on the oppositesides of the tissue defect or tissue to be reconstructed so as to resistthe high tension across the tissue defect or tissue to be reconstructedand between the mesh extensions in the opposing pair.
 19. The method ofclaim 14, wherein the tissue defect or the tissue to be reconstructed isabdominal tissue, and wherein each mesh extension is passed throughabdominal tissue adjacent to the abdominal tissue defect or theabdominal tissue being reconstructed.
 20. The method of claim 19,wherein the implantable mesh has at least four mesh extensions comprisedof mesh and arranged in at least two opposing pairs, and furthercomprising passing each of the mesh extensions in each opposing pairthrough the adjacent abdominal tissue such that each opposing pairresists high tension across the abdominal tissue defect or abdominaltissue to be reconstructed and between the mesh extensions in eachopposing pair.
 21. The method of claim 13, further comprising, afterpassing each mesh extension through tissue, securing the mesh extensionto the adjacent tissue with a fixation device to prevent the extensionbeing pulled back through the tissue.
 22. The method of claim 21,wherein the fixation device is one of a screw, a staple, a tack, or aclip.